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Treatment of Severe Heart Failure by Ultrafiltration

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Piergiuseppe Agostoni, Centro Cardiologico Monzino
ClinicalTrials.gov Identifier:
NCT00360958
First received: August 3, 2006
Last updated: January 27, 2016
Last verified: January 2016
  Purpose
Patients with severe congestive heart failure show increased fluid body content which is often resistant to conventional diuretic therapy. Therefore, chronic heart failure patients have frequent access to the emergency room and hospital for hemodynamic instability. Ultrafiltration is a simple renal replacement therapy which reduces fluid overload. The purpose of this study is to determine whether periodic ultrafiltration sessions maintain patients in stable clinical condition and reduce hospitalisations as well as access to emergency heart failure treatment.

Condition Intervention Phase
Severe Congestive Heart Failure
Procedure: ultrafiltration
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ultrafiltration for the Chronic Treatment of Severe Congestive Heart Failure

Resource links provided by NLM:


Further study details as provided by Centro Cardiologico Monzino:

Primary Outcome Measures:
  • number of hospitalizations for heart failure [ Time Frame: End of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • long term major adverse clinical events including death [ Time Frame: End of study ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: August 2006
Study Completion Date: December 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ultrafiltration
Ultrafiltration treatment
Procedure: ultrafiltration
Active Comparator: Usual treatment
Usual HF treatment
Procedure: ultrafiltration

Detailed Description:
Patients with severe heart failure (New York Heart Association [NYHA] III-IV) and fluid overload will be randomized to ultrafiltration (UF group) or conventional medical treatment (Control group). Patients follow-up at least monthly visit for one year. Ultrafiltration will be repeated during follow-up in case of body weight gain due to fluid accumulation. Ultrafiltration will be performed during short term hospitalization.
  Eligibility

Ages Eligible for Study:   20 Years to 90 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Severe heart failure (NYHA III-IV) with fluid overload
  • Ejection fraction < 40%
  • Estimated fluid overload > 4 kg

Exclusion Criteria:

  • Severe renal insufficiency
  • Acute pulmonary edema and/or cardiogenic shock
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00360958

Locations
Italy
Centro Cardiologico Monzino
Milan, Italy, 20138
Sponsors and Collaborators
Centro Cardiologico Monzino
Investigators
Principal Investigator: Piergiuseppe Agostoni, MD.PhD Centro Cardiologico Monzino
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Piergiuseppe Agostoni, MD PhD, Centro Cardiologico Monzino
ClinicalTrials.gov Identifier: NCT00360958     History of Changes
Other Study ID Numbers: CCM S67/306 
Study First Received: August 3, 2006
Last Updated: January 27, 2016
Health Authority: Italy: Ministry of Health

Keywords provided by Centro Cardiologico Monzino:
ultrafiltration
heart failure
fluid overload

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 23, 2016